India’s Research Participant Protection Policy

August 1, 2013

In an editorial published online today in BMJ, bioethicist Jeremy Sugarman and other experts warn that action is urgently needed to deal with possible unintended consequences of Indiaâ€™s new policy to protect research participants.

Passed earlier this year, the Drugs and Cosmetics Act (First Amendment) Rules, was meant to mitigate ethical concerns with potential serious consequences for public health, as well as Indiaâ€™s viability as a continued global leader in clinical research. However, Sugarman and his co-authors highlight specific concerns that could lead to the policy having the opposite effect, including a table of the policyâ€™s â€œConditions attributable to clinical trial injury or death.â€ One of these is â€œuse of placebo in a placebo controlled trial,â€ to which the authors respond that â€œplacebos are not necessarily harmful. Indeed the use of a placebo is often the only way of truly assessing whether the agent under study is associated with undue risk or significant benefit.â€

Among the authors other concerns is the policyâ€™s call to compensate research participants for injury for â€œfailure of investigational product to provide intended therapeutic benefit,â€ arguing that the purpose of the trial is to determine just that.

The authors give short and anticipated long-term ramifications of the policy, noting that at least 35 collaborative research projects funded by the US National Institutes of Health have been suspended since March 2013, most investigating large scale public health problems. They also note that India is the main supplier of antiretrovirals to donor supported HIV treatment programs in developing countries, and the dramatic fall in clinical trial applications that is already taking place could have a ripple effect on the availability of registered drugs.

â€œIt is essential that the unintended consequences of the new policy are dealt with effectively but rapidly,â€ the authors write. â€œThe relevance, impact, and quality of global health research have been greatly strengthened by engagement of Indian scientists and participation of Indian research volunteers. Advances in health research need Indiaâ€™s leadership and participation.â€